National Institute for Medical Research – Muhimbili Research Centre in collaboration with Kenya Aids Vaccine Initiative (KAVI), conducted a Good Clinical Practice (GCP) and Good Clinical Laboratory Practice (GCLP) training. The GCP training was conducted from 20th -22nd November, 2017 and GCLP training was conducted from 23rd -24th November, 2017 at the Muhimbili University of Health and Allied Science- HDCHPE building in Dar es salaam, Tanzania.
A total of 48 participants attended the course including all TRIP study site teams (intervention and deferred). Participants were consistently engaged in interactive presentations and discussions on International Conference on Harmonization Good Clinical Practice (ICH GCP) and GCLP. Topics covered on GCP include 1. Introduction to GCP 2. Ethical Basis of GCP 3. Sponsor Responsibilities 4. Investigator Responsibilities 5. The Protocol/Phases of clinical trials 6. Informed Consent process 7. Essential Documents 8. Safety: Assessment and Reporting 9. Data Management 10. Standard operating procedures 11. Quality Assurance/Quality control systems
GCLP topics were: 1. Introduction to GCLP 2. Facilities and Safety 3. Analytical Plans and Protocols 4. Organization 5. Personnel and Equipment 6. Introduction to Quality Assurance 7. Introduction to Quality control 8. Quality control for Qualitative test 9. Quality for Quantitative test 10. Method Validation 11. Sample Management 12. Standard Operating Procedures 13. Quality Audit 14. Inventory and Stocks 15. Occurrence Management 16. External Quality assessment 17. Source data record and reporting 18. Laboratory Information management system 19. Regulatory inspection 20. Quality Manual 21. Customer service 22. Accreditation.
Facilitators from Kenya Aids Vaccine Initiative (KAVI): Prof W. Jaoko, Prof Anzala, Dr Gaudensia Mutua, Mr Bashir Farrah Ms Jackline Nyange.
Facilitators from National Institute for Medical Research (NIMR): Dr Sayoki Mfinang Dr Charles Makasi
A certificate was awarded to all participants after successful completion of the course.